From Zero to Top Enroller: How Milestone One Transformed a Hospital into a Clinical Trial Powerhouse

From Zero to Top Enroller:
How Milestone One Transformed a Public Hospital into a Clinical Trial Powerhouse

How does a busy hospital with no prior research infrastructure transform into one of the country's top-performing clinical trial sites? This case study demonstrates how Milestone One provided targeted support to overcome steep barriers, including limited clinical trial knowledge, heavy physician workload, slow contracting, and a lack of established processes, ultimately turning these challenges into a success story.

By building and training a motivated research team, streamlining administration, and providing hands-on operational oversight, Milestone One helped the hospital secure 18 clinical trial opportunities across multiple therapeutic areas. The site has already surpassed enrollment expectations, more than doubling patient projections in a global cUTI trial, while achieving flawless audit results with zero protocol deviations.

Download the full case study to discover how Milestone One’s proven model accelerates site readiness, drives exceptional performance, and builds sponsor confidence from day one.

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The Participation Gap: Expanding Access and Representation in Oncology Trials

Despite being critical to the development of new cancer therapies, oncology clinical trials continue to face a major hurdle: low patient participation and enrollment. This challenge is compounded by disparities in trial access and representation, often driven by socio-economic barriers, limited availability of trial sites—particularly in underserved or rural areas—and a general lack of awareness and education about clinical research among patients. In a study evaluating the overall participation of patients in Commission of Cancer clinical trials (which represent more than 70% of all oncology-focused trials in the US), only 7.1% of patients with cancer participated in a clinical trial.¹ Of all patients with GI-related malignancies, only .2% enrolled in clinical trials.²

So why do only a fraction of patients choose to enroll in a clinical trial within one of the most prevalent therapeutic areas for disease worldwide?

In oncology clinical trials, there is often a high burden on the patient due to the nature of disease manifestation, progression, and requirements for current treatment methods. There is also a lack of sites amongst community health centers and more rural geographies, which can create additional challenges for patients who cannot travel to larger hospital or university sites, where clinical trial involvement is more prevalent.

At Milestone One, our mission is to enable research-naïve sites to get involved in clinical research, increasing access to innovative and alternative therapies for patients who would otherwise not have such access. Our transformative approach to clinical research support helps alleviate the burden for sites through administrative and operational support. We help investigators and sites bring ground-breaking treatment options to their patients and gain the experience necessary to run clinical trials, regardless of size or location.

Discover how easy it is to become part of the future of clinical research

Research isn’t just reserved for large institutions anymore, and with Milestone One, you have the power to help bring innovative treatments to patients. If you’re ready to get involved in clinical trials but are unsure of how to start, we’d love to discuss your site’s needs today.

¹ Joseph M. Unger et al. National Estimates of the Participation of Patients With Cancer in Clinical Research Studies Based on Commission on Cancer Accreditation Data. JCO 42, 2139-2148(2024). DOI:. 10.1200/JCO.23.01030.

² Muhammad Muntazir Mehdi Khan, Muhammad Musaab Munir, Selamawit Woldesenbet, Mujtaba Khalil, Yutaka Endo, Erryk Katayama, Abdullah Altaf, Mary Dillhoff, Samilia Obeng-Gyasi, Timothy M. Pawlik, Disparities in clinical trial enrollment among patients with gastrointestinal cancer relative to minority-serving and safety-netting hospitals, Journal of Gastrointestinal Surgery, Volume 28, Issue 6, 2024, Pages 896-902, https://doi.org/10.1016/j.gassur.2024.03.027.

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Overcoming Distance and Disparity: Engaging Rural, Research-Naïve Sites in Clinical Trials

Meeting enrollment targets presents a challenge for almost every clinical trial. Yet, many sponsors miss the opportunity to reach eligible patients in “rural” and under-served geographic areas, which make up about 19% of the total population of the US,¹ due to the potential challenges of engaging smaller, potentially research-naive sites.

There remains a gap in clinical trial education, access, and enrollment for patients outside urban centers, particularly in therapeutic areas with highly complex protocols and ultra-specific eligibility requirements like oncology and gastroenterology. In a recent study of 44 phase 2 and 3 oncology clinical trials, only “19.4% of patients (7184 of 36,995) were from rural locations.”² From the sponsor’s point of view, community and local sites are often dismissed as enrollment options as they tend to have fewer patients overall. To the site, running a clinical trial may seem overwhelming and time-consuming where resources are already constrained. Finally, from the patient’s perspective, challenges in participating in trials can include travel feasibility, financial constraints, and a lack of education or general. ³ ⁴

However, by implementing clinical trials at rural and research-naive sites, patients can gain access to potential treatment options that were previously out of reach.⁵

At Milestone One, we understand the value of closing the access gap for underserved and diverse populations to increase patient outcomes⁶ and access to clinical trials. Through our intimate understanding of small and rural sites’ pain points, including financial concerns, time limitations, technology, and staffing shortages,⁷ we work to eliminate these barriers.

Milestone One focuses on setting up infrastructure at each site through administrative and operational support at no direct cost – so that investigators can focus on what matters most: their patients. This also allows sites and providers to gain experience running trials with less financial risk or the burden of administrative work during start-up. We tailor clinical trial support to each site during the education and startup process, evaluating their skillset, capacity, and need.

Ready to Take the First Step?

Clinical research is no longer reserved for large institutions. With Milestone One, physicians can confidently enter the research space, provide patients with access to cutting-edge treatments, and foster growth within their facility.

Contact us today and discover how easy it is to become part of the future of clinical research.

¹ Bharucha, Adil E, Chung Il Wi, Sushmitha Grama Srinivasan, Hyuckjae Choi, Phillip H Wheeler, Jennifer R Stavlund, Daniel A Keller, Kent R Bailey, and Young J Juhn. “Participation of Rural Patients in Clinical Trials at a Multisite Academic Medical Center.” Journal of clinical and translational science, July 12, 2021.
https://pmc.ncbi.nlm.nih.gov/articles/PMC8596068/#:~:text=Conclusions:,and%20urban%20participants%20in%20trials.

² Unger JM, Moseley A, Symington B, Chavez-MacGregor M, Ramsey SD, Hershman DL. Geographic Distribution and Survival Outcomes for Rural Patients With Cancer Treated in Clinical Trials. JAMA Netw Open. 2018 Aug 3;1(4):e181235. doi: 10.1001/jamanetworkopen.2018.1235. PMID: 30646114; PMCID: PMC6324281.
https://pubmed.ncbi.nlm.nih.gov/30646114/

^{3 4} Murthy, V. H., Sateren, W. B., Ford, J. G., Haynes, M. A., Gosschalk, A., Eberhardt, M. S., Ricketts, T. C., Probst, J. C., Phillips, C. D., Medicine, I. of, Baldwin, L.-M., Lara, P. N., & Advani, A. S. (2011a, March 31). Rural–urban differences in discussions of cancer treatment clinical trials. Patient Education and Counseling.
https://www.sciencedirect.com/science/article/abs/pii/S0738399111001248

⁵ Bhatia, S., Landier, W., Paskett, E. D., Peters, K. B., Merrill, J. K., Phillips, J., & Osarogiagbon, R. U. (2022, July 11). Rural-urban disparities in cancer outcomes: Opportunities for Future Research. Journal of the National Cancer Institute.
https://pmc.ncbi.nlm.nih.gov/articles/PMC9275775/

⁶ Bhatia, S., Landier, W., Paskett, E. D., Peters, K. B., Merrill, J. K., Phillips, J., & Osarogiagbon, R. U. (2022, July 11). Rural-urban disparities in cancer outcomes: Opportunities for Future Research. Journal of the National Cancer Institute.
https://pmc.ncbi.nlm.nih.gov/articles/PMC9275775/

⁷ Diaz, N. (January 17, 2025). “We have to Rethink Rural Healthcare”: Inside Intermountain’s coalition. Becker’s Hospital Review.
https://www.beckershospitalreview.com/healthcare-information-technology/we-have-to-rethink-rural-healthcare-inside-intermountains-coalition.html